Medefil, Inc. FDA Inspection Record
Medefil, Inc. is an FDA-registered facility (FEI 3001677091) located in GLENDALE HEIGHTS, IL, US. Registered operations: ANALYSIS; LABEL; MANUFACTURE; PACK; RELABEL; REPACK; STERILIZE. RegDataLab tracks 11 FDA inspections and 1 compliance action at this facility.
What FDA found at this site
- Latest inspection
- Apr 21, 2025: Voluntary Action Indicated (VAI)
- Inspections on record
- 11 (2 OAI, 7 VAI, 2 NAI)
- Last OAI inspection
- Sep 6, 2011
- Warning letters
- 1 listed by FDA for this FEI, latest Jun 10, 2010
- Recalls as the recalling firm
- 1, latest Feb 19, 2014
Inspections and what FDA cited
| Date | Result | What FDA cited |
|---|---|---|
| Apr 21, 2025 | Voluntary Action Indicated (VAI) | No citations listed |
| Mar 29, 2018 | Voluntary Action Indicated (VAI) | No citations listed |
| Jun 17, 2016 | Voluntary Action Indicated (VAI) | Procedures not in writing, fully followed (21 CFR 211.22(d)) Procedures for sterile drug products (21 CFR 211.113(b)) Procedures To Be in Writing (21 CFR 211.80(a)) Containers & Closures Clean, Sterilized, Pyrogen-free (21 CFR 211.94(c)) and 3 more |
| Sep 15, 2014 | Voluntary Action Indicated (VAI) | Procedures for sterile drug products (21 CFR 211.113(b)) Investigations of discrepancies, failures (21 CFR 211.192) Quality audits - auditor independence (21 CFR 820.22) Lack of or inadequate procedures (21 CFR 820.100(a)) and 1 more |
| Dec 20, 2012 | Voluntary Action Indicated (VAI) | Documented evaluation (21 CFR 820.50(a)(1)) Lack of System for Event Evaluations (21 CFR 803.17(a)(1)) |
| Aug 22, 2012 | No Action Indicated (NAI) | No citations listed |
| May 25, 2012 | Voluntary Action Indicated (VAI) | Lack of or inadequate receiving acceptance procedures (21 CFR 820.80(b)) Nonconforming product control (21 CFR 820.90(a)) Deviations from laboratory control requirements (21 CFR 211.160(a)) Scientifically sound laboratory controls (21 CFR 211.160(b)) and 1 more |
| Sep 6, 2011 | Official Action Indicated (OAI) | No citations listed |
| Jan 31, 2011 | No Action Indicated (NAI) | Design validation - Risk analysis (21 CFR 820.30(g)) Design input - documentation (21 CFR 820.30(c)) Documentation (21 CFR 820.75(a)) Design validation - user needs and intended uses (21 CFR 820.30(g)) and 4 more |
| Feb 11, 2010 | Official Action Indicated (OAI) | No citations listed |
Recalls
| Date | Class | Recall | Product and reason |
|---|---|---|---|
| Feb 19, 2014 | Class III | Z-1149-2014 | Heparin I.V. Flush Syringe is available is pre-filled polypropylene syringes, 100… The bar code that is printed on the Master Carton label does not correspond to the product code fully displayed on the Master Carton label… |
When each source was last refreshed
| Records | Last refreshed | Source as of | Status |
|---|---|---|---|
| Inspections | Nov 14, 2026 | Newest record Nov 5, 2026 | Current |
| Inspection citations | Nov 14, 2026 | Newest record Nov 5, 2026 | Current |
| Compliance actions (warning letters, injunctions and other action types) | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
| Warning letter text | Nov 14, 2026 | Newest record Nov 10, 2026 | Current |
| Recalls (Enforcement Report) | Nov 14, 2026 | Newest record Nov 11, 2026 | Current |
| Form 483s and inspection documents | Nov 13, 2026 | Newest record Nov 12, 2026 | Current |
| Import refusals | Nov 2, 2026 | Newest record Oct 22, 2026 | Current |
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Facility details
- Company
- Medefil Incorporated
- Location
- GLENDALE HEIGHTS, IL (US)
- Registration Expires
- Dec 31, 2026
- Operations
- ANALYSIS; LABEL; MANUFACTURE; PACK; RELABEL; REPACK; STERILIZE
- Source
- both